510(k) K102637
K102637 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "DYNAREX ULTRASOUND GEL". The FDA issued a decision of Substantially Equivalent on February 16, 2011. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Dynarex Corporation has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2011
- Date Received
- September 14, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Coupling, Ultrasound
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type